Pain after Implantation of total knee and hip arthroplasties
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Indication for implantation of a total hip arthroplasty. Indication for implantation of a total knee arthroplasty. Sufficient knowledge of German to understand the informed consent process and complete the questionnaires, as well as the ability to actively participate in physiotherapeutic treatment and the virtual reality intervention.
Exclusion criteria
Exclusion criteria: Acute fracture of the bone to be operated on. Revision surgery. Prosthesis exchange. Cognitive disorders. Substance use disorders (e.g., alcohol or drug addiction). Incapacity to consent or limited legal capacity. Epilepsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the difference in pain intensity on the NRS (Numerical Rating Scale) between Visit 1 and Visit 3, measured in the intervention and control groups. For this purpose, pain intensity is assessed on the NRS at rest, during activity, and as an average. The primary analysis is based on the NRS at rest. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the difference in pain intensity at various time points, at rest, during activity, and on average, between Visits 2 and 3, as well as between Visits 1 and 4 and Visits 1 and 5. Further secondary endpoints are the change in function and clinical outcome between Visit 1 and 4, based on the difference in the Knee Society Score and Harris Hip Score in the corresponding subgroups of patients who underwent knee or hip arthroplasty. In addition, the range of motion (ROM) of the knee joint is measured in the subgroup of patients who undergo knee arthroplasty as the difference between Visits 1 and 4. Based on this, changes in a pre-existing or newly occurring postoperative extension deficit are derived. Further secondary endpoints include patient satisfaction, analgesic requirements, and the use of walking aids at Visit 4. The use of rescue medication during the inpatient stay is also assessed. | — |
Countries
Germany
Contacts
Klinik für Orthopädische, Unfall -und Wiederherstellungschirurgie Campus Benjamin Franklin, Charité Universitätsmedizin Berlin